TORADOL 30 mg/1 ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

TORADOL 30 mg/1 ml Solution for Injection

Ketorolac Tromethamine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Toradol and what is it used for
2. What you need to know before you use Toradol
3. How to use Toradol
4. Possible side effects
5. Storage of Toradol
6. Contents of the pack and further information

1. What is Toradol and what is it used for

Toradol 30 mg/1 ml Solution for Injection contains the active substance ketorolac tromethamine, which belongs to a group of medicines called analgesics, anti-inflammatory and antipyretics.

Your doctor has prescribed Toradol for the short-term treatment of moderate to severe pain after surgery or for the treatment of pain caused by kidney colic.

2. What you need to know before you use Toradol

Tell your doctor if you have recently undergone or are going to undergo stomach or intestinal surgery before receiving/taking/using Toradol, as Toradol may sometimes worsen wound healing in the intestine after surgery.

Do not use Toradol

• if you have an active peptic ulcer,
• if you have any history of gastrointestinal ulceration, bleeding or perforation,
• if you vomit blood, have black stools or bloody diarrhea,
• if you are allergic (hypersensitive) to ketorolac tromethamine or other non-steroidal anti-inflammatory drugs, or to any of the other ingredients of this medicine (listed in section 6),
• if you have had asthma attacks (difficulty breathing), acute rhinitis (inflammation of the nasal mucosa), urticaria (allergic reaction on the skin with itching), angioedema (swelling of the face, tongue or throat that causes difficulty breathing) or other allergic reactions after using substances with similar action (e.g. acetylsalicylic acid, ibuprofen or other non-steroidal anti-inflammatory drugs),
• if you have severe heart failure (your heart does not work well),
• if you have moderate to severe renal failure (your kidney does not work correctly),
• if you have a bleeding disorder, coagulation disorders or cerebral hemorrhage (bleeding in the brain),
• if you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests,
• during childbirth,
• if you are in the third trimester of pregnancy,
• if you are breastfeeding your baby,
• as a preventive analgesic before or during surgery, due to the risk of bleeding,
• The injectable form of Toradol should not be used for epidural or intrathecal administration, as it contains alcohol.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Toradol.

Severe skin reactions have been reported with the use of non-steroidal anti-inflammatory drugs, which manifest as red spots, generalized redness of the skin, ulcers or widespread rash accompanied by symptoms similar to those of the flu, including fever (see section 4). The rash can progress to generalized blisters or skin peeling. The greatest risk of severe skin reactions is in the first weeks of treatment, but they could start to develop until several months after administration of the medicine (see section 4). If you have developed a severe skin reaction after using Toradol, do not restart treatment at any time. If you develop a skin rash or these symptoms, discontinue treatment with Toradol and contact your doctor or seek medical attention immediately.

Be careful with Toradol

• If you experience gastrointestinal pain (irritation, ulceration or perforation), rectal bleeding or vomiting, you should discontinue treatment immediately and inform your doctor immediately.
• If you are over 65 years old or are debilitated, precautions should be taken and the minimum effective doses should be used.
• If you are taking medications that increase the risk of ulcer or gastrointestinal bleeding, such as heparin, antiplatelet agents, pentoxifylline, corticosteroids, thrombolytics and antidepressants of the selective serotonin reuptake inhibitor or serotonin and norepinephrine reuptake inhibitor type.
• If you have had inflammatory bowel disease (ulcerative colitis, Crohn's disease).
• If you have kidney disease, your doctor may consider it necessary to perform certain tests during treatment with this medicine.
• Toradol may cause fluid retention, be careful if you have heart failure or high blood pressure (hypertension).
• If you are being treated with anticoagulants (medicines used to "thin" the blood: coumarins or heparin).
• If you experience some symptoms of liver dysfunction such as itching or redness of the skin during treatment, you should discontinue treatment immediately and inform your doctor as soon as possible.
• If you experience redness of the skin, mucosal lesions or any other sign of hypersensitivity or anaphylactic reaction (severe allergic reaction), you should discontinue treatment and inform your doctor immediately.
• If you have complete or partial nasal polyp syndrome (a disease that affects the inside of the nose and paranasal sinuses due to the growth of benign tumors that obstruct breathing), angioedema (hives, a superficial swelling) or bronchospasm (difficulty breathing).
• If you are taking other medications, such as methotrexate, as Toradol may modify or enhance the effect of these.

Consult your doctor, even if any of the above circumstances have occurred to you at any time.

Cardiovascular precautions

Medicines like Toradol may be associated with a moderate increase in the risk of heart attacks ("myocardial infarctions") or strokes. This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, a history of strokes, or think you may be at risk for these conditions (for example, you have high blood pressure, diabetes, high cholesterol or are a smoker), you should consult your doctor or pharmacist about this treatment.

Similarly, this type of medicine may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Precautions during pregnancy and in women of childbearing age

Because the administration of medicines like Toradol has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of Toradol is contraindicated.

During breastfeeding, the administration of Toradol is contraindicated.

For women of childbearing age, it should be taken into account that medicines like Toradol have been associated with a decrease in fertility.

Other medicines and Toradol

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicine.

It is not recommended to use Toradol with: other non-steroidal anti-inflammatory drugs (including acetylsalicylic acid and selective cyclooxygenase-2 inhibitors), anticoagulants (coumarins or heparin at full doses), antiplatelet agents (such as acetylsalicylic acid, ticlopidine or clopidogrel), pentoxifylline, probenecid or lithium salts.

Be careful if you are being treated with any of the following medicines: corticosteroids, thrombolytics (medicines administered to favor the elimination of blood clots), antidepressants, methotrexate, antihypertensives or furosemide (a diuretic used to increase urine elimination).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Toradol if you are in the last 3 months of pregnancy, as it may harm your baby or cause problems during childbirth. It may cause kidney and heart problems in your baby. It may affect your tendency and that of your baby to bleed and delay or prolong childbirth more than expected. You should not take Toradol during the first 6 months of pregnancy unless it is strictly necessary and your doctor indicates it. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, Toradol may cause kidney problems in your baby if taken for more than a few days, which can cause low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

Consult your doctor if you are trying to become pregnant or are undergoing fertility treatment, as the use of this medicine may affect your ability to have children.

Do not use Toradol during pregnancy, as it may be harmful to your baby (see section precautions during pregnancy and in women of childbearing age).

Small amounts of the medicine may appear in breast milk, therefore, do not use Toradol if you are breastfeeding.

Do not use Toradol during childbirth.

Driving and using machines

Caution is recommended when driving or using machines, especially at the beginning of treatment, as you may experience drowsiness, dizziness, vertigo, insomnia or depression during treatment with Toradol.

Toradol contains ethanol

This medicine contains 100 mg of alcohol (ethanol) per ml, which is equivalent to 100 mg/ml (10% p/v). The amount in 1 ml of this medicine is equivalent to less than 3 ml of beer or 1 ml of wine.

The small amount of alcohol in this medicine does not produce any noticeable effect.

This medicine contains less than 1 mmol of sodium (23 mg) per ml; i.e., it is essentially "sodium-free".

3. How to use Toradol

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dose of Toradol 30 mg/1 ml Solution for Injection should be adjusted according to the severity of the pain and the patient's response, trying to administer the minimum effective dose. The recommended initial dose of Toradol 30 mg/1 ml Solution for Injection by intramuscular (im) or intravenous (iv) route is 10 mg followed by doses of 10-30 mg every 4 to 6 hours, as needed to control the pain. In cases of intense or very intense pain, the recommended initial dose is 30 mg of ketorolac.

The recommended maximum daily dose is 90 mg for non-elderly adults and 60 mg for elderly patients.

Remember to use your medicine.

Your doctor will indicate the duration of your treatment with Toradol. Do not stop treatment before.

Treatment with Toradol 30mg /1 ml Solution for Injection should be started in a hospital setting. The maximum duration of treatment should not exceed 2 days. In the event of subsequent oral treatment, the total duration of treatment with ketorolac should not exceed 7 days.

In the treatment of pain caused by kidney colic, a single dose of 30 mg by intramuscular (im) or intravenous (iv) route is recommended.

If you have received ketorolac by parenteral route and are switched to oral treatment, the total daily combined dose of the two oral and parenteral presentations should not exceed 90 mg in adults and 60 mg in elderly patients.

In most patients, intramuscular or intravenous therapy with ketorolac provides adequate analgesia. However, opioid analgesics may be used in conjunction when, due to the intensity of the pain, the maximum recommended doses of ketorolac are not sufficient or the opioid requirements are to be reduced.

When morphine is administered in combination with ketorolac, the daily dose of morphine needed is significantly reduced.

Intramuscular injection should be administered slowly and deeply into the muscle.

If you are over 65 years old, precautions should be taken and lower doses should be used. It is recommended not to exceed a total daily dose of 60 mg.

Do not use ketorolac if you have moderate or severe renal failure. If you have mild renal failure, you should receive lower doses of ketorolac (half of the recommended dose, not exceeding a total daily dose of 60 mg) and periodic determinations of renal function tests will be performed.

Use in children and adolescents

It is not recommended to administer it to children under 16 years old.

If you use more Toradol than you should

If you have used more Toradol than you should, consult your doctor or pharmacist immediately.

Abdominal pain, nausea, vomiting, hyperventilation (increased pulmonary ventilation), gastroduodenal ulcer, erosive gastritis, gastrointestinal bleeding and renal dysfunction may occur, which remit when the use of the medicine is discontinued.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91.562.04.20.

If you forget to use Toradol

Do not use a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

The frequency of occurrence of adverse reactions is unknown because it cannot be estimated from the available information.

Gastrointestinal Disorders: These are the most frequent adverse effects. The following may occur:

• peptic ulcer, perforation, or gastrointestinal hemorrhage, sometimes fatal, especially in the elderly.
• nausea, vomiting,
• diarrhea, flatulence, constipation,
• dyspepsia (digestion disorder), gastritis (inflammation of the stomach mucosa), abdominal pain,
• melena (blood in stool), hematemesis (blood in vomit),
• ulcerative stomatitis (lesions in the mouth),
• worsening of ulcerative colitis and Crohn's disease (inflammatory intestinal diseases),
• abdominal discomfort,
• belching,
• feeling of fullness,
• esophagitis (inflammation of the esophagus), pancreatitis (inflammation of the pancreas),
• rectal bleeding,
• dysgeusia (taste alteration).

Metabolic and Nutritional Disorders:

• anorexia (loss of appetite),
• hyperkalemia (increased potassium in the blood) and
• hyponatremia (decreased sodium in the blood).

Nervous System and Musculoskeletal Disorders:

• aseptic meningitis (inflammation of the meninges),
• seizures,
• dizziness,
• dry mouth,
• headache,
• hyperkinesia (excess activity),
• myalgia (muscle pain),
• paresthesia (loss of sensitivity),
• sweating.

Psychiatric Disorders:

• abnormal dreams,
• thought disorder,
• anxiety, depression, insomnia,
• euphoria, hallucinations, psychotic reactions,
• somnolence,
• decreased concentration capacity,
• nervousness.

Renal and Urinary Disorders:

• acute renal failure, "kidney pain" with hematuria (blood in urine) and hyperazotemia (accumulation of nitrogen in the blood) or without them,
• pollakiuria (repeated urination of small amounts),
• urinary retention,
• interstitial nephritis (kidney inflammation),
• nephrotic syndrome (abnormal protein excretion in urine),
• oliguria (decreased urine production).

As with other prostaglandin synthesis inhibitors, signs of renal failure (e.g., elevated creatinine and potassium levels) may appear after a dose of Toradol.

Cardiovascular Disorders:

• edema (swelling due to fluid accumulation),
• hypertension (high blood pressure) and
• heart failure, are associated with treatment with non-steroidal anti-inflammatory drugs.
• bradycardia (decreased heart rate),
• hot flashes, palpitations,
• hypotension (decreased blood pressure),
• chest pain (any discomfort or abnormal sensation in the chest).

Reproductive System and Breast Disorders: female infertility.

Respiratory, Thoracic, and Mediastinal Disorders:

• bronchial asthma,
• dyspnea (feeling of shortness of breath),
• pulmonary edema (fluid accumulation in the lungs),
• bronchospasm (difficulty breathing),
• epistaxis (nosebleed).

Hepatobiliary Disorders:

• alteration of liver function tests,
• hepatitis (inflammation of the liver),
• cholestatic jaundice (yellowing of the skin),
• liver failure (liver disorders).

Skin and Subcutaneous Tissue Disorders:

• Vesiculobullous cutaneous hypersensitivity reactions, including toxic epidermal necrolysis (Lyell's disease) and Stevens-Johnson syndrome (lesions on skin and mucous membranes), may very rarely occur.
• exfoliative dermatitis (skin peeling),
• maculopapular exanthema (rash),
• pruritus (itching), urticaria (red hives),
• angioedema (hives),
• facial erythema (redness).

Immune System Disorders:

• hypersensitivity reactions (allergy),
• anaphylaxis (allergic reaction),
• laryngeal edema (inflammation of the larynx),
• anaphylactoid reactions (acute allergic reaction). Anaphylactoid reactions, like anaphylaxis, can be fatal.

Blood and Lymphatic System Disorders:

• purpura (bleeding in the skin),
• thrombocytopenia (decreased platelets in the blood),
• hemolytic uremic syndrome (anemia and blood in stool),
• pallor.

Eye Disorders:

• vision changes.

Ear and Labyrinth Disorders:

• tinnitus (ringing in the ear),
• hypacusia (decreased hearing),
• vertigo.

General Disorders and Administration Site Conditions:

• asthenia (lack of strength),
• edema (swelling due to fluid accumulation),
• injection site reactions,
• fever,
• polydipsia (increased thirst).

Investigations:

• elevated serum urea and creatinine levels,
• elevated potassium levels,
• weight gain,
• prolonged bleeding time,
• alteration of liver function tests.

Injuries, Poisoning, and Procedural Complications:

• hematomas (bruises),
• post-surgical hemorrhage (after an operation).

If you observe any other reaction not described in this prospectus, consult your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Medicines and Health Products Agency's Pharmacovigilance System: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Toradol

Keep the ampoules in their original packaging to protect them from light.

Keep this medicine out of the sight and reach of children.

Do not use Toradol after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewage system or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Toradol Composition

• The active ingredient is ketorolac tromethamine. Each ampoule contains 30 mg of ketorolac tromethamine.
• The other ingredients are ethanol, sodium chloride, water for injectable preparations, and sodium hydroxide.

Product Appearance and Package Contents

Toradol 30 mg/1 ml injectable solution is available in cardboard boxes with 6 glass ampoules of 1 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Manufacturer

Atnahs Pharma Denmark ApS

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Date of Last Revision of this Prospectus: January 2024

"Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es"